The Birth Control Files: Eight Devices, What They Promised, What They Delivered

Sixty years, eight devices, one pattern of corporate concealment

The Paragard prescribing information includes a statement on page five, under section 13.1, headed “Carcinogenesis, Mutagenesis, Impairment of Fertility.” The manufacturer writes: “Adequate long-term studies in animals to assess the carcinogenic potential of a copper-containing IUS have not been performed. The genotoxic potential of a copper-containing IUS has not been evaluated.” [1]

The device has been on the American market since 1984. Approximately 380 milligrams of copper are inserted into a woman’s uterus and left there for up to a decade. The manufacturer states, in the document that accompanies every device, that whether this exposure causes cancer has never been studied.

CooperSurgical’s Paragard marketing describes the product as “hormone free,” “the only non-hormonal IUD,” and “over 99% effective.” The word “untested” does not appear.

Both documents are current. Both are signed by the same company. One is shown to consumers. The other is filed with the FDA.

The essay that follows is the reconciliation of those two documents, applied to eight contraceptive devices across sixty years of American reproductive medicine. Every claim here is drawn from four document types: manufacturers’ prescribing information, internal company communications produced through litigation, findings of federal courts, and peer-reviewed studies of the products in question. No claim rests on activist testimony alone.

The devices tell the same story from different angles. What they were sold as. What the label admits. What the company knew. And what it took, in the one documented case where the device was withdrawn, to force that outcome.

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The One That Was Withdrawn

That case is the Ortho Evra contraceptive patch.

Ortho-McNeil Pharmaceutical, a Johnson & Johnson subsidiary, received FDA approval for Ortho Evra in November 2001. [2] The product was a weekly transdermal delivery system for ethinyl estradiol and norelgestromin, the same synthetic estrogen and progestin present in most combined oral contraceptives, redesigned to deliver through the skin rather than through the digestive tract.

The clinical claim was simple. A once-a-week patch replaces daily pill compliance and produces equivalent contraception with fewer missed doses. Marketing framed the product around convenience and freedom from the mental burden of remembering.

The transdermal delivery had a pharmacological consequence the marketing did not emphasize. Oral estrogen passes through the liver on first absorption, where a significant portion is metabolized before reaching general circulation. Transdermal estrogen bypasses this liver processing entirely. Circulating estrogen levels reached by patch users were approximately sixty percent higher than levels reached by users of a comparable 35-microgram oral contraceptive. [2]

Estrogen levels correlate with clotting risk. By 2005, four years after approval, the FDA required Johnson & Johnson to add a bolded warning to the Ortho Evra label stating that patch users faced approximately double the venous thromboembolism risk of oral contraceptive users. Independent epidemiological studies published in the following years put the multiplier between 1.5 and 2.4. [3, 4] FDA adverse event reports began accumulating deaths in young, healthy women from pulmonary embolisms, strokes, and deep vein thromboses.

Johnson & Johnson faced thousands of wrongful death and injury suits. Settlement figures accumulated into the hundreds of millions of dollars. In 2014, Ortho-McNeil withdrew Ortho Evra from the American market. A bioequivalent generic, Xulane, remained available under a different manufacturer. The Ortho Evra brand did not.

Ortho Evra is the one product in this essay that was withdrawn.

The withdrawal is instructive. It required a black-box warning, thousands of lawsuits, hundreds of millions in settlements, twelve years on the market, and an unknown number of deaths never conclusively counted in any public register. Even then, the withdrawal was not a recall on safety grounds. It was a corporate decision consistent with declining sales and rising litigation cost.

That is what withdrawal looked like when it happened. The seven devices that follow are what continued marketing looks like when the same sequence, safety signal ignored, adverse events accumulated, litigation mounted, settlements paid, does not produce that outcome.

Fertility is not a disease. It is the default operation of a healthy reproductive system in a woman between menarche and menopause. Every device on the list that follows treats that default as a problem requiring pharmacological or mechanical intervention. The pill was the template. Take a healthy state, declare it a condition, sell a chronic pharmaceutical to a healthy person, and price the intervention as a subscription. Every subsequent device on the list extends the template. Longer duration of disruption. Greater difficulty of discontinuation. Progressive removal of the user’s ability to reverse the decision without medical assistance.

The corporate concealment pattern is what unites the list. A. H. Robins on the Dalkon Shield. Merck on NuvaRing. Upjohn and Pfizer on Depo-Provera. Merck on Nexplanon. Bayer on Mirena and Skyla. Every device has a concealment record documented in litigation, internal company memos, and FDA correspondence. The pattern is not exceptional. It is repeatable. The Dalkon Shield established it in 1970. Every device that followed refined it.

The taxonomy of invasiveness organizes the seven devices below. Daily oral. Monthly intravaginal. Multi-month injected. Multi-year implanted subcutaneous. Multi-year implanted intrauterine, first copper, then hormonal. And finally the historical anchor that established the pattern the others refined.

The essay closes on the fertility awareness method that has been available for thirty years, is more effective than most of the devices on this list, and is taught in no major American medical school.

How You Would Explain This to a Six-Year-Old

A woman’s body has a rhythm. Every month, her body prepares for a baby. If no baby comes, the rhythm starts over. This is how her body is made to work.

Some people make products that stop the rhythm. Pills. Rings. Shots. Rods that go under the skin. Small devices that sit inside her where a baby would grow.

Every product comes with a folded piece of paper. The paper says what can go wrong. Blood clots. Broken bones. Cancer. Sadness that will not lift. Not being able to have a baby later, even when she wants one. Sometimes, dying.

The companies that sell the products wrote the paper. They filed it with the government. They know what it says.

The women who take the products almost never see the paper. The doctor does not read it to them. The pharmacy does not open it. The paper stays folded inside the box.

For sixty years, that has been the arrangement.

There is another way to prevent a baby. A woman can learn to read her own body and know when she can get pregnant and when she cannot. It works nearly as well as any product on the list, and better than most.

Almost no doctor teaches this. No company sells it. No one profits from a woman who reads her own body.

That is the whole story.

The Pill

The pill’s central mechanism is documented in the prescribing information for every combined oral contraceptive on the American market. The synthetic estrogen and progestin flood the endocrine system at levels sufficient to suppress the hypothalamic-pituitary signaling that would ordinarily trigger ovulation. The brain reads the signal as pregnancy. The ovaries go quiet. No egg matures. The “period” that occurs during the placebo week is not menstruation. It is withdrawal bleeding, engineered into the original formulation in the 1960s to make the drug feel biologically familiar.

The pharmacological mechanism is pregnancy mimicry. That is not a description offered by critics. It is what the drug does, described in the labels of Yaz, Sprintec, Apri, Junel Fe, and Aviane, the five most commonly prescribed oral contraceptives in the United States. [5, 6, 7, 8, 9]

The labels acknowledge the consequences. All five carry the FDA’s most serious warning category, the boxed warning, for cardiovascular events. Deep vein thrombosis, pulmonary embolism, stroke, and myocardial infarction are listed as known risks. The Yaz patient labeling states plainly that blood clots can form “in the legs, lungs, eyes, heart, or brain” and that a woman can die or be permanently disabled from a clot caused by this medication. [5]

The Yaz label contains a section titled “Do Birth Control Pills Cause Cancer?” The first sentence of the answer, in the manufacturer’s own document, reads: “It is not known if hormonal birth control pills cause breast cancer.” [5] Not that the evidence is reassuring. Not that studies suggest no association. That the manufacturer does not know.

The Apri label acknowledges that long-term users of more than eight years and women who started at an early age face increased breast cancer risk. [7] The Sprintec, Junel, and Aviane labels contain a passage that belongs in every prescription: “The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.” [6, 8, 9]

The safety data on the pills being sold today is drawn from studies of pills sold decades ago. The manufacturers say so, in the documents they file with the FDA.

Independent research has done what the manufacturer trials did not. In 2016, a Danish national cohort study published in JAMA Psychiatry followed over one million women for up to fourteen years. Women using combined oral contraceptives had a 23 percent higher rate of first-time antidepressant use than non-users. Among adolescents aged 15 to 19, the increase was 80 percent. [10] A follow-up study by the same research group, published in the American Journal of Psychiatry in 2018, associated hormonal contraceptive use with increased rates of suicide attempts and completed suicides. The strongest associations were among the youngest users. [11]

Neither study is cited in any of the five prescribing documents.

The corporate name attached to Yaz is Bayer HealthCare Pharmaceuticals. Sprintec is Barr Laboratories. Apri is Teva. Junel Fe and Aviane originated with Warner-Chilcott, Barr, and Wyeth. In every case, the manufacturer publishes the harm and declines to communicate it.

The Pill: Read the Insert

NuvaRing

The NuvaRing is a flexible plastic ring inserted into the vagina once every three weeks. It releases etonogestrel and ethinyl estradiol through the vaginal mucosa into general circulation, achieving the same ovulation suppression as an oral contraceptive without the daily dose. Organon Incorporated received FDA approval in October 2001. Schering-Plough acquired Organon. Merck acquired Schering-Plough. NuvaRing generated $623 million in revenue for Merck in 2012. [12]

The FDA approval rested on a clinical trial of sixteen women.

Two of the sixteen experienced massive estrogen spikes in the first days of use. Two more showed unexplained estrogen spikes midway through the cycle. These four data points, one-quarter of the study population, disappeared from the thirty-page summary document Organon submitted to the FDA. The full data appeared only in the hundreds of pages of backup documentation, discovered years later during litigation. [13]

The vaginal delivery route introduced a pharmacological problem the trial did not investigate. The ring is a polymer matrix. Diffusion of the hormones through polymer material varies with temperature. Product labeling recommends storage between 68 and 77 degrees Fahrenheit. What happens to the ring in a Phoenix delivery truck, a Texas summer purse, or a bathroom cabinet next to a hot shower has never been tested. A 2013 Vanity Fair investigation of the product documented this gap in stark terms. To that date, no post-manufacture stability test had been performed on the product. [13]

The clinical consequences began appearing in adverse event reports within years of approval. In 2011, an FDA-commissioned Kaiser Permanente study found NuvaRing users faced a 56 percent higher clot risk than users of comparable oral contraceptives. [14] In 2012, a Danish nationwide study following over one million women found NuvaRing users had 6.5 times the venous thromboembolism risk of women using no hormonal contraception, and approximately 90 percent higher risk than users of second-generation oral contraceptives. [15]

Erika Langhart was twenty-four years old on Thanksgiving Day 2011, bound for law school. Her boyfriend found her writhing on the floor, struggling for air. She died within hours of a pulmonary embolism. Her mother, Karen Langhart, a physician, spent three days in the intensive care unit watching her daughter die. Every nurse and physician on the ward knew the pattern. “Each and every one of them had personal and professional stories to tell,” she said afterward. [13]

Court documents produced during subsequent litigation revealed Merck’s response to safety concerns. A 2009 internal email from marketing supervisor Thomas Hadley asked: “Do we have anything for the reps to use to help direct the conversation away from DVT? Didn’t we create a letter for them to use reactively?” A Field Flash communication from 2005 provided sales representatives with scripted language to deflect physician questions about deep vein thrombosis, closing with a suggested compliance question: “Based on this information are you still confident and comfortable in prescribing NuvaRing to your patients seeking hormonal contraception?” [16]

More than 230 deaths associated with NuvaRing have been reported to the FDA’s adverse event database. Merck settled thousands of wrongful death and injury cases without acknowledging causation. NuvaRing remained on the American market. Merck did not stop selling. Merck stopped talking about deep vein thrombosis.

Your Daughter's Life, Their Bottom Line: Inside the NuvaRing Machine

Depo-Provera

Depo-Provera is a suspension of medroxyprogesterone acetate injected intramuscularly every three months. Upjohn Company developed it in the 1960s. Pfizer, which acquired Upjohn’s parent Pharmacia in 2002, holds the product today. Tens of millions of women worldwide have received Depo-Provera injections.

The FDA rejected Depo-Provera three times.

The first rejection came in 1967. Upjohn’s own animal studies had produced malignant mammary tumors in beagles and monkeys. The FDA cited the carcinogenicity data explicitly. A brief 1974 approval was reversed within months when the cancer concerns resurfaced. A 1978 application was denied on grounds including birth defects in exposed fetuses and the absence of any compelling medical need for the drug given safer alternatives.

The evidence was not marginal. Three dogs in Upjohn’s studies died from drug-induced diabetes, adrenal atrophy, and malignant tumors. The company argued that beagles were “unsuitable for comparison testing” because all dogs were “acutely sensitive to progesterone,” a biological claim that would have surprised the veterinary literature.

In 1987, the FDA changed its testing requirements. Dog studies were no longer required for progestin approval. Rat and mouse studies became the standard. Medroxyprogesterone acetate did not cause cancer in mice with the reliability it did in dogs and primates. Depo-Provera received FDA approval in 1992. [17]

Between 1994 and 2000, the United States Agency for International Development shipped 41.9 million units of Depo-Provera to the developing world at a cost exceeding $40 million. This occurred while the drug carried black-box warnings on bone density loss in the United States. Zimbabwe’s Minister of Health had banned the drug in 1981, calling it a tool of racial population control. In the United States, 84 percent of Depo-Provera users are Black women, though Black women comprise 13 percent of the population. Seventy-four percent of users are low-income.

The current prescribing information acknowledges what the animal data suggested. The FDA’s 2004 black-box warning states that women should not use Depo-Provera for longer than two years because of “significant loss of bone mineral density” that “may not be completely reversible.” [17] Long-term users show osteopenia rates of 68 percent and osteoporosis rates of 30 percent, figures generated by women in their twenties and thirties, not by post-menopausal populations.

More recent evidence has emerged that the manufacturers have not incorporated. A 2024 study documented a 2.4-fold increased risk of intracranial meningioma among long-term Depo-Provera users. [18] Meningiomas, while typically benign, can compress brain tissue and require surgical resection. Women who received Depo-Provera in their teens and twenties are being followed for a brain tumor risk that no prescribing document mentions.

The medroxyprogesterone acetate molecule binds not only to progesterone receptors but to glucocorticoid receptors, the receptors that mediate the body’s stress response. Clinical trial data acknowledge depression and mood changes among adverse reactions. The mechanism by which a synthetic progestin activates the body’s stress signaling is not disclosed in patient counseling. Women are told about efficacy and convenience. They are not told the drug binds to the same receptors that mediate chronic stress.

Depo-Provera: The Shot Heard Round the World

Nexplanon

Nexplanon is a matchstick-sized rod inserted under the skin of the upper arm, releasing etonogestrel continuously for three years. Its predecessor, Implanon, was replaced by Nexplanon in 2011. The newer version was made radio-opaque because the older one could not be located when it went missing.

Missing implants are documented in the current prescribing information. Merck, the manufacturer, acknowledges that implants inserted too deeply “may not be palpable” and that “the localization and/or removal can be difficult or impossible.” [19] Post-marketing surveillance has documented implants in the pulmonary artery, a rod designed to sit in an arm, found in the blood vessels of the lung. Removal of a migrated implant requires surgery under general anesthesia. When an implant cannot be located, the woman continues to receive synthetic hormone for whatever remaining lifespan the device has, with no way to stop the exposure.

The insertion procedure takes approximately 28 seconds. Removal, in clinical trial data, takes an average of 3.5 minutes, seven times as long. Difficult removals extend to 60 minutes, risking nerve damage, blood vessel injury, and scarring. [19]

Nexplanon carries an FDA-approved indication for use in postpubertal adolescents. The prescribing document states: “No clinical studies have been conducted in women less than 18 years of age.” The efficacy and safety in adolescents is “expected to be the same” as in adult women. [19] Expectation, in the manufacturer’s own words, substituted for evidence.

The document contains further admissions. Studies “did not include many overweight women,” and effectiveness “may become less effective in overweight women over time.” Approximately 40 percent of American women are classified as obese. The manufacturer states it cannot determine effectiveness in nearly half its potential user population.

Clinical trial data reveal the routine consequences. In the pivotal trials, 11.1 percent of women discontinued the implant specifically because of unpredictable bleeding, whether that meant prolonged bleeding lasting weeks, frequent bleeding, or absence of bleeding entirely. Headaches occurred in 24.9 percent of users. Vaginitis affected 14.5 percent. Weight increase averaged 2.8 pounds at one year and 3.7 pounds at two years, figures that continue to compound across successive implants. [19]

Depression appeared in 5.5 percent of trial participants, with 1.0 percent discontinuing because of it. Among United States trial subjects, the discontinuation-for-depression figure rose to 2.4 percent. Emotional lability affected 6.5 percent overall and led to 6.1 percent discontinuation in the American subset. The prescribing document instructs healthcare providers to “carefully observe women with a history of depression,” a phrase that acknowledges what the drug can do without describing what such observation should consist of.

The implant releases etonogestrel into circulation continuously for three years. Etonogestrel is the same synthetic progestin used in NuvaRing. In pill form, a woman who develops depression can stop the drug within 24 hours. In implant form, the drug continues to release until the device is surgically extracted, assuming it can be located. “Reversible contraception” is a marketing term, not a pharmacological fact.

The Implant Deception: A Critical Analysis of Nexplanon and Implanon

The Copper IUD

The Paragard is the only copper intrauterine device available on the American market. CooperSurgical Inc. manufactures it. The device is a T-shaped plastic frame wound with copper wire and fitted with copper sleeves on the arms. It contains approximately 380 milligrams of copper in total, inserted into the uterus and left in place for up to ten years.

The copper is the active ingredient. Copper ions released into the uterine environment interfere with sperm mobility and, according to the prescribing document, may prevent implantation of a fertilized egg. [1] The mechanism is chemical toxicity applied selectively to sperm cells and, in cases where fertilization occurs anyway, to the embryo.

Section 13.1 of the prescribing information, quoted in the opening of this essay, states that no long-term studies of a copper-containing intrauterine system have been conducted in animals for carcinogenic potential and no evaluation has been performed for genotoxic potential. [1] The device has been on the American market since 1984. Approximately 380 milligrams of a metal used industrially as a biocide and algicide have been placed inside millions of women’s bodies without carcinogenicity testing.

The device is regulatory-grandfathered. When Congress passed the Medical Device Amendments in 1976, products already on the market were classified according to risk categories and permitted to remain. [20] The Paragard’s copper T predecessor was among them. A new device seeking initial approval today would face testing requirements that Paragard has never had to meet.

The documented adverse effects follow from the chemistry. Copper generates reactive oxygen species, meaning free radicals that damage cellular components. Copper depletes zinc, molybdenum, and other minerals through competitive absorption and metabolic interference. Excess copper accumulates in the liver and brain. The prescribing document lists heavy menstrual bleeding, dysmenorrhea, expulsion, perforation, and pelvic inflammatory disease among adverse reactions. Post-marketing data include Stevens-Johnson Syndrome, systemic hypersensitivity reactions, and device breakage, meaning pieces of copper wire lodged in tissue after removal attempts. [1]

Wilson’s disease is listed as a contraindication in the prescribing document. Wilson’s is a condition in which the body cannot process copper normally, resulting in copper accumulation with psychiatric, neurological, and hepatic consequences. The document effectively acknowledges that copper toxicity, when it occurs, produces the symptoms women without Wilson’s disease report after Paragard insertion: anxiety, depression, fatigue, cognitive impairment. The document lists these as adverse reactions without connecting them to the mechanism the Wilson’s contraindication tacitly admits.

The corporate name attached to Paragard is CooperSurgical. The company has never funded a long-term carcinogenicity study of its device.

Copper IUD: Untested

The Hormonal IUD

The Mirena releases levonorgestrel, a synthetic progestin, into the uterus continuously for up to eight years. Skyla is the same drug in a smaller device with a three-year duration. Kyleena and Liletta are further variants. Bayer HealthCare Pharmaceuticals holds the primary marketing rights for Mirena and Skyla. Other hormonal IUDs are manufactured by different companies with functionally identical mechanisms.

The marketing claim central to hormonal IUDs is that the drug acts locally in the uterus, with minimal systemic absorption. The prescribing information for Kyleena discloses that the device releases approximately 17.5 micrograms of levonorgestrel daily at insertion, and that blood levels of the synthetic hormone reach 100 to 200 picograms per milliliter. [21] The claim of local action is inconsistent with measurable systemic hormone levels.

In 2016, the Danish nationwide cohort study published in JAMA Psychiatry included hormonal IUD users among the hormonal contraceptive population associated with elevated depression and antidepressant use. [10] In 2018, the follow-up study associated hormonal contraception with suicide attempts and completed suicides. [11] Bayer’s response to the 2016 publication was not to redesign the product or update the counseling protocol.

In December 2023, JAMA published a Danish nationwide cohort study by Mørch and colleagues examining levonorgestrel-releasing intrauterine devices specifically. Following 78,595 first-time users of hormonal IUDs and matched controls, the study found a 40 percent increased breast cancer risk (hazard ratio 1.4) among users compared with non-users. Point estimates suggested increasing risk with duration of use: 1.3 for 0 to 5 years, 1.4 for 5 to 10 years, 1.8 for more than 10 years. The absolute increase amounted to approximately 14 additional cases per 10,000 women within five years of use, rising with continued exposure. [23]

A 2024 Swedish national cohort confirmed the finding with a 10 to 20 percent increased breast cancer risk. Multiple meta-analyses corroborate. The evidence base is not marginal.

The prescribing information for Kyleena and Mirena lists breast cancer under adverse reactions and contraindicates the device in women with current or past breast cancer. [21, 22] The 40 percent risk elevation from the JAMA 2023 data does not appear in patient counseling materials. Women receiving hormonal IUDs are told the device is “over 99 percent effective.” The 40 percent breast cancer risk increase is not part of that conversation.

Clinical trial data document 22 percent early discontinuation among Kyleena users due to adverse events. Twenty-four percent developed vulvovaginitis. Twenty-two percent developed ovarian cysts. Twenty-one percent reported pelvic pain. Fifteen percent developed acne. Fifteen percent developed headaches. Ten percent reported breast tenderness. Six to seven percent developed depression. Six to seven percent reported decreased libido. [21]

The French national pharmacovigilance database contains a natural experiment on underreporting. When French media coverage brought hormonal IUD side effects to public attention in 2017, adverse event reports to French regulators increased fifteen-fold. The rate of underlying adverse events had not changed. What changed was recognition. For years, women had been experiencing depression, hair loss, acne, and sexual dysfunction and not connecting the symptoms to the device. [24]

Bayer has paid over $12 million in settlements for Mirena perforation cases as of 2023. The device remains on the American market, marketed as offering “peace of mind.”

Hormonal IUDs Cause Depression and Increase Breast Cancer: The Evidence They Buried

The Dalkon Shield

Four days before A. H. Robins signed the contract to purchase the Dalkon Shield in June 1970, the company’s own director of pharmaceutical research reported that the device’s tail string had not been subjected to any formal stability testing and that the plastic used had been cleared by the FDA for packaging meat, not for implantation in humans. Seventeen days after purchase, a company orientation report circulated to thirty-nine executives, including the chairman, president, and multiple vice-presidents. It noted that the tail string had a “wicking” tendency: it could draw bacteria from the vagina up into the uterus. The report recommended “a careful review.” [25, 26]

A. H. Robins began national sales six months later. It never conducted wicking studies on the string.

The Shield’s commercial life rested on a single published study. In February 1970, Dr. Hugh J. Davis of Johns Hopkins reported in the American Journal of Obstetrics and Gynecology that only 1.1 percent of Shield users became pregnant over twelve months of use. [27] He did not disclose his 35 percent ownership stake in the Dalkon Corporation. He did not disclose that the study’s average patient duration was 5.54 months rather than the twelve claimed. He did not disclose that his statistical timeline made complete follow-up impossible. A. H. Robins purchased 199,000 reprints of the article and distributed them to physicians.

The company knew the pregnancy figure was wrong. When Dr. Fred Clark visited Davis in Baltimore three months before purchase, he found a longer data set showing a 3.1 percent pregnancy rate, nearly three times the published figure. Clark’s confidential memo circulated to senior officials. Independent studies subsequently reported rates of 5.6 percent at Kaiser-Permanente, 10.1 percent at Beth Israel Boston, and higher. [25]

On October 31, 1973, A. H. Robins’s own project coordinator, Allen Polon, wrote in an internal memo: “A pregnancy rate of 1.1 percent is stated which is not valid.” He recommended destroying the promotional literature. By that date, A. H. Robins had captured 56 to 59 percent of the American IUD market. [25]

Wayne Crowder, a quality control supervisor at a Robins subsidiary, identified the wicking problem in March 1971. He conducted his own experiment. He placed sections of the Shield’s tail string in beakers of water, and demonstrated that liquid climbed the string past both knots. He proposed heat-sealing the string ends with a cigarette lighter, at an estimated cost of five to ten cents per Shield. The company sold each Shield for up to $4.35. His supervisor told him that his conscience “didn’t pay his salary.” [28] A Robins engineer investigating alternative string materials found that Gore-Tex, which would not wick, cost 6.1 cents per string compared to 0.63 cents for the existing multifilament Supramid. For one million Shields, the difference was approximately $54,000. Robins’s average net earnings at the time were nearly $70,000 per day. The company chose not to switch. [25, 26]

Beginning in 1973, women wearing the Dalkon Shield began developing spontaneous septic abortions in the middle trimester of pregnancy, a condition previously seen almost exclusively in cases of illegal or self-induced procedures. By August 1974, the FDA had received reports of eleven deaths and 209 serious illnesses from septic abortions in Shield wearers. The Centers for Disease Control confirmed that fatal septic abortions occurred twice as frequently in Shield users as in users of other intrauterine devices. [25, 26]

A. H. Robins suspended American marketing in June 1974 but continued shipping to developing countries through USAID until August 1975. The company took no action to remove the estimated 600,000 Shields still inside American women until a “Dear Doctor” letter in September 1980, six years after the deaths began. The company’s first direct communication to women themselves came in October 1984, more than a decade after the deaths began.

By the time A. H. Robins filed for bankruptcy in August 1985, more than 14,000 lawsuits had been filed. At least 88,000 women in the United States were injured. Hundreds of thousands developed pelvic inflammatory disease. At least eighteen women died in the United States. That figure is the count Robins acknowledged and the FDA received. The toll across the seventy-nine countries where the device was distributed is not comprehensively documented.

Judge Miles Lord of the U.S. District Court in Minneapolis had supervised the discovery process against active company obstruction and document destruction. On February 29, 1984, he addressed three senior Robins officers in his courtroom. His statement, read aloud after the officers’ attorneys instructed them not to respond to his questions: “When the time came for these women to make their claims against your company, you attacked their characters. You inquired into their sexual practices and into the identity of their sex partners. You exposed these women, and ruined families and reputations and careers, in order to intimidate those who would raise their voices against you.” [29]

The Dalkon Shield established the template. Every device on this list refined it.

The Depth Charge in the Womb

Objections

Several objections will be raised against this account. Each is addressed here at the point where a critical reader would raise it.

The devices remain legal, available, and covered by insurance. This is not the question the essay asks. Every device in this taxonomy is legally sold in the United States, prescribed by physicians in good standing, and administered under standard consent protocols. The essay does not argue for prohibition. It argues for disclosure. Informed consent requires that a woman receive the information the manufacturer has already published in the document accompanying the device. That the document exists is not sufficient if the physician does not review it, the pharmacist does not open it, and the woman does not know it is there.

Modern versions are safer than earlier formulations. The prescribing documents disagree. The Sprintec, Junel, and Aviane labels state, in identical language, that “the effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.” [6, 8, 9] The safety data for the pills sold today draws on studies of pills sold decades ago. This is disclosed by the manufacturers in their own documents.

Correlation is not causation. The devices act by biochemical mechanisms the manufacturers describe. Combined oral contraceptives suppress ovulation by delivering synthetic hormones that mimic pregnancy. The Depo-Provera molecule binds to glucocorticoid receptors. Levonorgestrel from a hormonal IUD reaches measurable systemic blood concentrations. Copper released from a Paragard generates free radicals. The observed harms follow mechanistically from what the devices are designed to do. The mechanism is not correlational. It is described in the prescribing document.

The argument is anti-woman. The women who brought these cases are not spokespeople for the framing they were injured by. The archive of testimonies runs to tens of thousands. Wayne Crowder, the Chap Stick quality control supervisor who tried to fix the Dalkon Shield string, was told by his own supervisor that his conscience did not pay his salary. The demographic history of these devices targeting Black and Indigenous populations is documented in the Depo-Provera USAID record and in the Greenland IUD campaign, where 4,500 devices were inserted in indigenous Danish subjects between 1966 and 1970, including in girls as young as thirteen. Presenting that history is not anti-woman. It is anti-concealment.

Fertility awareness does not work. The symptothermal method, taught by Toni Weschler in Taking Charge of Your Fertility and studied under controlled protocols since the 1990s, produces a method failure rate of 0.4 to 2 percent per year with correct use. The 2007 German study published in Human Reproduction tracked 900 women over a decade and put the method failure rate at 0.4 percent, better than the copper IUD’s 0.6 percent and comparable to the pill’s 0.3 percent. [30, 31] The evidence base is peer-reviewed. It is not the rhythm method. It is not calendar tracking. It is direct observation of biological signs cross-verified with basal body temperature.

Disclosure will frighten women into unwanted pregnancies. The essay’s purpose is not to alarm. It is to reconcile two documents that the manufacturer publishes at the same time and asks the reader to treat as compatible: the marketing description and the prescribing information. A woman deciding between contraceptive options is entitled to both. The absence of that disclosure is what informed consent, as a doctrine, exists to prevent.

The Method That Has No Manufacturer

The marketing document promised freedom, convenience, discretion, and peace of mind. The prescribing information disclosed blood clots, stroke, depression, breast cancer risk, meningioma risk, bone density loss, migration, extraction complication, sterility, and death. The litigation record proved that manufacturers knew the difference and made the commercial calculation to continue selling. Sixty years, eight devices, seven still selling, one withdrawn, and one corporate concealment pattern established by A. H. Robins in 1970 and refined by every successor.

The Ortho Evra patch was withdrawn from the American market in 2014 after thirteen years, thousands of lawsuits, hundreds of millions in settlements, a black-box warning, and an unquantified number of deaths. That is what withdrawal required.

The symptothermal method achieves 99.4 percent effectiveness with correct use. The figure is drawn from the 2007 German study of 900 women published in Human Reproduction. [30] It is comparable to the pill’s 0.3 percent method failure rate and superior to the copper IUD’s 0.6 percent. The method requires a basal thermometer and instruction in observation of three fertility signs: cervical fluid, basal body temperature, and cervical position. The instruction is available in a book that has been in print since 1995. [31] The method uses no synthetic hormones and no device.

It is taught in no major American medical school. It is prescribed by no gynecologist as a first-line contraceptive option. It is covered by no insurance plan as a primary method. The reason is not efficacy. Efficacy is documented. The reason is that no one can sell it. Every device in the taxonomy above has a corporate name attached: Bayer, Merck, Pfizer, CooperSurgical, Johnson & Johnson, A. H. Robins in bankruptcy. The method that works has no one to defend it because no one profits from it.

That is the pattern. That has always been the pattern. And every document required to see it, the prescribing labels, the internal memos, the FDA correspondence, the court findings, the peer-reviewed studies, has been available all along. Folded up inside the box.

Taking Charge of Your Fertility

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References

Prescribing Information and FDA Documents

[1] CooperSurgical, Inc. Paragard (intrauterine copper contraceptive) Full Prescribing Information. Revised 2020. FDA-approved patient labeling.

[2] Ortho-McNeil Pharmaceutical, Inc. Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) Prescribing Information. Original FDA approval November 20, 2001. Label updated with bolded warning on venous thromboembolism risk, November 2005.

[5] Bayer HealthCare Pharmaceuticals. Yaz (drospirenone and ethinyl estradiol) Tablets Prescribing Information. FDA Reference ID: 5177006.

[6] Barr Laboratories. Sprintec (norgestimate and ethinyl estradiol) Tablets Prescribing Information. Revised January 2011.

[7] Teva Canada Limited. Apri 21 and Apri 28 (desogestrel and ethinyl estradiol) Tablets Prescribing Information. DIN 02352346 / 02352354.

[8] Junel Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) Prescribing Information. ANDA076380. Revised January 2025.

[9] Teva Pharmaceuticals USA. Aviane (levonorgestrel and ethinyl estradiol) Tablets Prescribing Information. Revised August 2024.

[12] Organon USA, Inc. NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) Prescribing Information. Original FDA approval October 2001.

[17] Pfizer Inc. Depo-Provera (medroxyprogesterone acetate) Contraceptive Injection Prescribing Information. FDA Label Reference ID: 4078731. Black-box warning on bone mineral density loss added November 2004.

[19] Merck & Co., Inc. Nexplanon (etonogestrel implant) Prescribing Information. Revised October 2018. FDA Reference ID: 4422253.

[21] Bayer HealthCare Pharmaceuticals. Kyleena (levonorgestrel-releasing intrauterine system) Prescribing Information. FDA Reference ID: 4847293.

[22] Bayer HealthCare Pharmaceuticals. Mirena (levonorgestrel-releasing intrauterine system) Prescribing Information.

Peer-Reviewed Studies

[3] Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 μg of ethinyl estradiol. Contraception. 2006;73(3):223-228.

[4] Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 μg of ethinyl estradiol. Contraception. 2007;76(1):4-7.

[10] Skovlund CW, Mørch LS, Kessing LV, Lidegaard Ø. Association of hormonal contraception with depression. JAMA Psychiatry. 2016;73(11):1154-1162.

[11] Skovlund CW, Mørch LS, Kessing LV, Lange T, Lidegaard Ø. Association of hormonal contraception with suicide attempts and suicides. American Journal of Psychiatry. 2018;175(4):336-342.

[14] Sidney S, Cheetham TC, Connell FA, et al. Recent combined hormonal contraceptives (CHCs) and the risk of thromboembolism and other cardiovascular events in new users. Contraception. 2013;87(1):93-100.

[15] Lidegaard Ø, Nielsen LH, Skovlund CW, Løkkegaard E. Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10. BMJ. 2012;344:e2990.

[18] “Depot Medroxyprogesterone Acetate and Risk of Meningioma in the US.” JAMA Neurology, 2024. Documenting 2.4-fold increased risk of intracranial meningioma among long-term Depo-Provera users. See also: Roland N, Neumann A, Hoisnard L, et al. Use of progestogens and the risk of intracranial meningioma: national case-control study. BMJ. 2024;384:e078078.

[23] Mørch LS, Meaidi A, Corn G, Iversen L, Hannaford PC, Lidegaard Ø. Association of levonorgestrel-releasing intrauterine device with breast cancer. JAMA. 2023;330(24):2345-2353.

[24] Dolker S, Sauvaget A. Adverse events reported for Mirena levonorgestrel-releasing intrauterine device in France and impact of media coverage. Pharmacoepidemiology and Drug Safety. 2019;28(8):1078-1085.

[27] Davis HJ. The Shield Intrauterine Device: A Superior Modern Contraceptive Device. American Journal of Obstetrics and Gynecology. 1970;106(3):455-456.

[30] Frank-Herrmann P, Heil J, Gnoth C, et al. The effectiveness of a fertility awareness based method to avoid pregnancy in relation to a couple’s sexual behaviour during the fertile time: a prospective longitudinal study. Human Reproduction. 2007;22(5):1310-1319.

Investigative Journalism and Historical Sources

[13] Brenner M. Danger in the Ring. Vanity Fair, December 2013.

[16] Court documents, In re NuvaRing Products Liability Litigation, MDL No. 1964, U.S. District Court, Eastern District of Missouri. Internal Merck communications produced during discovery, including 2005 Field Flash sales communications and 2009 marketing correspondence.

[25] Mintz M. At Any Cost: Corporate Greed, Women, and the Dalkon Shield. New York: Pantheon Books, 1985.

[26] Perry S, Dawson J. Nightmare: Women and the Dalkon Shield. New York: Macmillan, 1985.

[28] Wayne Crowder deposition testimony, March 27, 1981. Cited in Mintz (1985) and Perry & Dawson (1985).

[29] Judge Miles W. Lord, remarks to A. H. Robins officers, February 29, 1984. U.S. District Court, District of Minnesota.

[31] Weschler T. Taking Charge of Your Fertility: The Definitive Guide to Natural Birth Control, Pregnancy Achievement, and Reproductive Health. 20th Anniversary Edition. William Morrow Paperbacks, 2015.

Regulatory Documents

[20] Public Law 94-295, Medical Device Amendments of 1976. 90 Stat. 539.

Additional Background

Block J. Everything Below the Waist: Why Health Care Needs a Feminist Revolution. St. Martin’s Press, 2019.

Hill S. This Is Your Brain on Birth Control: The Surprising Science of Women, Hormones, and the Law of Unintended Consequences. Avery, 2019.

Grigg-Spall H. Sweetening the Pill: or How We Got Hooked on Hormonal Birth Control. Zero Books, 2013.

Seaman B. The Doctor’s Case Against the Pill. Peter H. Wyden, Inc., 1969.

Brighten J. Beyond the Pill: A 30-Day Program to Balance Your Hormones. HarperOne, 2019.

Takeshita C. The Global Biopolitics of the IUD: How Science Constructs Contraceptive Users and Women’s Bodies. MIT Press, 2011.

Companion Essays in the Unbekoming Birth Control Series

Unbekoming. The Pill: Read the Insert. February 2026.

Unbekoming. Your Daughter’s Life, Their Bottom Line: Inside the NuvaRing Machine. September 2025.

Unbekoming. Depo-Provera: The Shot Heard Round the World. October 2025.

Unbekoming. The Implant Deception: A Critical Analysis of Nexplanon and Implanon. October 2025.

Unbekoming. Copper IUD: Untested. August 2025.

Unbekoming. Hormonal IUDs Cause Depression and Increase Breast Cancer: The Evidence They Buried. August 2025.

Unbekoming. The Depth Charge in the Womb: An Essay on the Dalkon Shield. February 2026.

Unbekoming. Taking Charge of Your Fertility: The Symptothermal Method. February 2026.

New Biology Clinic

For those of you looking for practitioners who actually understand terrain medicine and the principles we explore here, I want to share something valuable. Dr. Tom Cowan—whose books and podcasts have shaped much of my own thinking about health—has created the New Biology Clinic, a virtual practice staffed by wellness specialists who operate from the same foundational understanding. This isn’t about symptom suppression or the conventional model. It’s about personalized guidance rooted in how living systems actually work. The clinic offers individual and family memberships that include not just private consults, but group sessions covering movement, nutrition, breathwork, biofield tuning, and more. Everything is virtual, making it accessible wherever you are. If you’ve been searching for practitioners who won’t look at you blankly when you mention structured water or the importance of the extracellular matrix, this is worth exploring. Use discount code “Unbekoming” to get $100 off the member activation fee. You can learn more and sign up at newbiologyclinic.com

Truth Be Told: I’ve Accepted an Invitation to Speak on The Unvaccinated

On September 17th, I’ll be giving a one-hour presentation titled The Unvaccinated as part of a six-hour livestream called Truth Be Told. This is the first time I have accepted an invitation to an event, and I have been honoured with the opening act. The livestream begins at 12pm EST.

Vaccination is the subject closest to my heart, and this is another opportunity to spread the word. The format will preserve the pen name.

Jamie Andrews (Decentralized Science Projects) and Agent131711 (Dinosaurs) will also be presenting. Jamie’s Virology Control Studies work led to an interview here last year. Agent’s research shaped my essays on vitamin D and dinosaurs. Tickets are here. The code UNBEKOMING is $5 off and applies automatically at that link. Replay available afterwards. Hope you can make it.